Kornimate/medical-research-clean huggingface dataset:
evaluation of visual - motor development in children with retinopathy of prematurity

Conditions: Premature Retinopathy; Visual Impairment; Motor Delay

Summary: the aim of this study was to investigate the eye structure, visual impairment, visual motor development and motor coordination of children between 2-6 ages that had applied to diod laser photocoagulation and intravitreal anti - vascular endothelial growth factor treatment.

there are three different groups in this study. children between 2-6 ages that had applied to diod laser photocoagulation and intravitreal anti - vascular endothelial growth factor treatment will have evaluated with snellen test, titmus fly test, optical kohlerans tomography, beery-buktenica developmental test of visual motor integration, peabody developmental motor scales-ii, world health organization quality of life - bref and state - trait anxiety inventory.

Eligibility criteria:
inclusion criteria: * age range between 2-6 years of age * gestational age range 26-34. be between weeks * to be diagnosed with retinopathy of prematurity * neurological, hereditary and not having metabolic disease * compliance with visual examinations and physiotherapy evaluations * to be children and parents who agree to participate in the study exclusion criteria: * to be a child who does not comply with optical kohlerans tomography (oct) * not participating in one or more of the eye examination or physiotherapy assessments * being children and parents who do not agree to participate in the study
study of an experimental new drug, pparγ agonist taken by mouth by participants with advanced or metastatic cancer

Conditions: Neoplasm

Summary: an open-label, phase i, dose escalation study of cs-7017 administered by mouth in sequential cohorts of 3 to 6 participants with advanced or metastatic malignancies.


Eligibility criteria:
inclusion criteria: * histologically or cytologically diagnosed advanced or metastatic malignancy that is refractory to, not curable with, or not eligible for standard treatment(s). * 18 years or older * eastern cooperative oncology group (ecog) performance status less than or equal to 2. * resolution of any toxic effects of prior therapy (except alopecia) to national cancer institute common terminology criteria for adverse events v3.0 grade less than or equal to 1. * adequate organ and bone marrow function. * willing to use effective contraceptive while on treatment through at least 3 months thereafter. * negative pregnancy test for females of childbearing potential. * echocardiogram with ejection fraction within normal range. exclusion criteria: * anticipation of need for a major surgical procedure or radiation therapy during the study. * treatment with chemotherapy, hormonal therapy, other thiazolidinediones, radiotherapy, minor surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas, mitomycin c, immunotherapy, biological therapy, or major surgery) of study treatment start. * participants with clinically significant pleural or pericardial effusion (participants with minimal pleural effusion may be eligible at the investigator's discretion). * clinically significant active infection, which requires antibiotic therapy, or human immunodeficiency virus (hiv)-positive participants receiving antiretroviral therapy.

Keywords: pparγ agonist advanced or metastatic malignancies tumor cancer
absorption kinetics and efficacy of vitamin d enriched supplements in older adults.

Conditions: Vitamin D Deficiency

Summary: the proposed study will examine vitamin d bioavailability when 20µg of vitamin d is consumed in 5 different forms: i) a vitamin d enriched pre-formed mixed micelle dairy drink ii) a vitamin d enriched olive oil dairy drink iii) a vitamin d enriched fish oil dairy drink iv) a vitamin d enriched fat-free dairy drink

this postprandial study will recruit healthy males and females aged 18 and over. upon completion of informed consent procedures and successful screening, the volunteers will complete 4 study visits. participants will consume a standardised meal the evening before each test day, and will arrive in the morning to the research facility in ucd after an overnight fast of 12 hours. on the study test days, volunteers will be given one of the following vitamin d treatments in a dairy drink, followed by a low-fat breakfast. 1. mixed micelles 2. olive oil 3. fish oil 4. fat-free participants will also be given a low-fat lunch 5 hours after the supplement is consumed. volunteers will be cannulated by a trained phlebotomist on arrival, and a fasting blood sample will be taken. following ingestion of the vitamin d supplements blood samples will be taken at 0,2,4,6, and 8 hours post ingestion. a 10ml sample will be collected at each time point. in total, 60ml of blood will be collected over 24 hours. the participant's food intake will be recorded during the visit.

Eligibility criteria:
inclusion criteria: healthy men and women exclusion criteria: pregnant or lactating smokers individuals that are not free-living e.g. institutes where meals are prepared in bulk such as nursing homes, prisons etc. an inability to read, write or understand english following a strict prescribed diet for any reason, insulin dependent diabetes, coeliac disease, crohn's disease disease or condition that requires chronic therapeutic nutritional or medical treatment. those taking supplemental vitamin d those who have been on a sun holiday in the last 2 months
serious adverse drug reaction and their preventability

Conditions: Adverse Drug Reaction

Summary: introduction: elderly aged over 65 years accounted for around 17.5% of the french general population. adverse drug reactions (adr) are common in this population. in elderly subject, prevalence of adrs ranged from 4.3% to 63.0%. aim: to describe the serious adr in elderly subjects aged over 65 years and assess their preventability. methods: a retrospective study was conducted at the regional pharmacovigilance center of champagne-ardenne (northeast of france) between january and may 2013. patients aged over 65 years who presented a serious adr notified to the regional pharmacovigilance center were included in the study.

introduction: elderly aged over 65 years accounted for around 17.5% of the french general population. adverse drug reactions (adr) are common in this population. in elderly subject, prevalence of adrs ranged from 4.3% to 63.0%. age itself is not a risk factor for adrs but is a factor of severity of adr. according to the world health organization (who), more than half of all adrs are considered to be preventable in elderly subjects. they are most often the result of a mistake during the prescription phase, or the monitoring phase, or may be due to poor compliance or inappropriate self-medication. drug prescription is based on guidelines derived from clinical trial that have not included elderly subject with multiple comorbidities. data regarding drug safety from clinical trials alone are insufficient, hence the need to continue the monitoring of adr after drug marketing. aim: to describe the serious adr in elderly subjects aged over 65 years and assess their preventability. methods: a retrospective study was conducted at the regional pharmacovigilance center of champagne-ardenne (northeast of france) between january and may 2013. patients aged over 65 years who presented a serious adr notified to the regional pharmacovigilance center were included in the study.

Eligibility criteria:
inclusion criteria: * patients aged over 65 years * patients who presented a serious adverse drug reaction notified to the regional pharmacovigilance center of champagne-ardenne

Keywords: elderly adverse drug reactions hospitalized subjects community-dwelling
inflammatory status of visceral adipose tissue in obese patients related to periodontitis severity

Conditions: Parodontitis; Obesity; Metabolism Disorders

Summary: the research aims to compare the inflammatory status of visceral adipose tissue from obese patients depending on the presence and severity of periodontitis, in order to establish a potential causal link between the severity of the bacterial contamination and insulin resistance.

recruitment of patients will be achieved in the department of digestive surgery. it will involve 122 patients with severe obesity undergoing bariatric surgery scheduled within the digestive surgery department. patients recruited will be examined for evaluating the presence and severity of periodontitis, and separated into either group 1: for patients with moderate or severe periodontitis, and or group 2: for patients without or with mild periodontitis. the day before the surgery, blood sample will be collected for the analysis of circulating metabolic and inflammatory markers. collection of stimulated saliva, periodontal sample and faeces samples (50 g) will also be carried out for bacteria determination. during the surgical procedure, a sample of visceral adipose tissue (50 g) will be collected and used for periodontal bacteria detection and inflammatory markers analyses.

Eligibility criteria:
inclusion criteria: * patient eligible for bariatric surgery scheduled within the digestive surgery * patient affiliated to social security system or equivalent exclusion criteria: * treatment with steroids or anti-inflammatory drugs in progress (or stopped for less than one month) * patients who received antibiotics within 3 months prior to the bariatric surgery for whatever duration * dental current (or older than 3 months) * participation in another research protocol
factors determining quality of life related to respiratory status according to gender of chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to evaluate with sufficient precision and according to gender the determining independent factors of quality of life related to respiratory status of patient with moderate to severe copd.


Eligibility criteria:
inclusion criteria: * adult patient who has a clinical visit for their usual follow-up. * patient with copd with at least a three month follow up exclusion criteria: * current or history of asthma * current participation in an interventional clinical study

Keywords: quality of life copd patients evaluation according to gender the determining independent factors of quality of life related to respiratory status of patient with moderate to severe copd
a study on the tolerability and early efficacy of hlf1-11 in patients with proven candidaemia

Conditions: Candidaemia

Summary: this is a phase-i, double-blind, randomized study with hlf1-11 to study the tolerability and early efficacy of hlf1-11 compared to standard fluconazole therapy in hospitalized patients with invasive candida infection.

rationale for the study choice of drug fluconazole is considered "standard care" for the treatment of candida infections, including candidaemia in hospitalized patients. preclinical data has demonstrated that hlf1-11 possesses potent antimycotic effects against candida sp and, importantly, to be synergistic with fluconazole, whereby candida strains that are fluconazole-resistant become sensitive through the addition of hlf1-11 choice of patient population based on preclinical data hlf1-11 has been shown to possess potent effects on candida albicans models in vitro and in vivo. furthermore, candidaemia (bloodstream candida infection) is one of the most likely settings to elicit a therapeutic response since the product is presented as an intravenous formulation as previously mentioned, fluconazole and hlf1-11 exhibit a synergistic effect in preclinical studies, whereby the effect of fluconazole is enhanced by the addition of hlf1-11.

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before admission in the study. * patients in whom candida species have been confirmed by 2 consecutive blood cultures within 12 hours. * patients who have not received systemic administration of antifungal agents or who have started such administration within 48 hours prior to entry. * patients who have hepatic and renal parameters within 2x uln (upper level of normality) at screening. exclusion criteria: * patients with a history of hypersensitivity to fluconazole or hlf1-11. * patients who have been treated with fluconazole for at least 1 week within the previous 4 weeks. * patients with a history of fluconazole-resistant candida species within 12 weeks. * neutropenic patients with neutrophil count below 0.5x10\^9/l. * patients who are treated with terfenadine, triazolam, cisapride, and ergotamine, which are contraindicated for concomitant use with fluconazole. * patients known to have aids or who are hiv-positive. * females who have a positive pregnancy test at baseline or are capable of child-bearing i.e. without appropriate contraception (chemical or mechanical). * patients with suspected candida osteomyelitis, endocarditis, or meningitis. * patients who have received an investigational drug within three months prior to the study. * patients with a concomitant medical condition, in whom, in the opinion of the investigator, participation may create an unacceptable risk for the patient. * patients considered inappropriate by the pi for enrollment in the study, for any reason.

Keywords: hlf1-11 candida candidaemia lactoferrin
additional kif6 risk offers better adherence to statins

Conditions: Cardiovascular Diseases; Dyslipidemia

Summary: many patients prescribed statins to lower their cholesterol stop taking their statin over time. the purpose of this study is to determine whether providing subjects their kif6 carrier status (associated with increased cardiovascular event risk) will improve adherence to statin medications.

coronary heart disease (chd) remains a significant problem in the us, causing about 1 of every 5 deaths in 2005. in 2009, approximately 1.3 million americans will have a new/recurrent myocardial infarction. coronary heart disease (chd) includes myocardial infarction, stable or unstable angina, demonstrated myocardial ischemia detected by noninvasive testing, and a history of coronary artery procedures (such a stent or bypass). currently, "statins" are recommended by the aha to manage elevated low-density lipoprotein-cholesterol (ldl-c). unfortunately, the discontinuation of statins is quite substantial. for example, a large cohort study of older patients found that 2-year statin adherence rates were approximately 40% for acute coronary syndrome patients, 36% for chronic coronary artery disease, and 25% for primary prevention and is associated with increased mortality, hospitalizations, and costs. recently, the kinesin 6 (kif6) gene has been associated with a 30-55% increase in cardiovascular events in individuals carrying one or two risk variants (\~57% of the white population) in multiple prospective studies. furthermore, kif6 carriers receiving a "statin" have a substantial greater cardiovascular risk reduction (-34 to 50%) when using a "statin" compared to those that are non-carriers using a statin (6 to 20%). in this prospective, open label, trial, recruited subjects recently started on statin therapy will be provided information about their kif6 carrier status and followed for 6 months to determine their "statin" adherence. additionally, quality of life and factors adherence will be measured at baseline and after 6 months. finally, pharmacy records will be evaluated for up to 1-year to determine statin discontinuation rates.

Eligibility criteria:
inclusion criteria: * men and women at least 18 years of age * new statin prescription * medco rationalmed® program * data contains patient contact information (e.g. phone number) * data contains provider contact information * willing to sign informed consent and send kif6 test results to their provider exclusion criteria: * statin prescription in the previous 6 months * subject refusal to participate in this study (record reason from subject) * physician refusal to participate in this study (record reason from provider) * anticipated statin discontinuation within 6 months * any condition that would prevent the subject from completing the 6 month study follow-up period * subject with "no contact red flag" * subject residing in ny, nj, ma, pa

Keywords: adherence statins kinesin-like protein 6
auditory intranerve stimulation study

Conditions: Auditory; Nerve

Summary: this feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. patients who will undergo an acoustic neuroma removal surgery and are functional deaf 3. age ≥ 18 years 4. women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists exclusion criteria: 1. disabilities in addition to hearing impairment which might interfere with the study procedure 2. pregnant and breast feeding woman or other vulnerable population
light at night study

Conditions: Bipolar Disorder; Light Sensitivity

Summary: the purpose of this mechanistic study is to examine light sensitivity (melatonin suppression) in people with bipolar depression i, and compare it to healthy controls. this is not a treatment study.

the bipolar disorder i and healthy control arms are recruited from the existing heinz c. prechter bipolar research program at the university of michigan.

Eligibility criteria:
inclusion criteria: * bmi 18-30 kg/m2 * appropriate sleep schedules according to study staff. sleep schedule is self-reported and confirmed through a sleep diary * healthy eyes as ascertained by eye exam at university of michigan kellogg eye center * willing and able to maintain stable sleep schedule during study. * participants will be breathalyzed and undergo urine drugs screens at every lab visit * acknowledge and understand that participants cannot drive themselves home after certain lab visits. note that the research team will provide a travel stipend of $10 per visit to offset potential rideshare/taxi costs exclusion criteria: * color blindness

Keywords: circadian light intensity
s-100b and neuron-specific enolase (nse) in spinal trauma

Conditions: Spinal Cord Injury

Summary: the investigators are studying the clinical worth of the serum markers s-100b and nse in patients with spinal cord injuries e.g. in patients with vertebral fractures. if there is a injury to the neuronal structures these two proteins could be secreted into the serum and add evidence to the severity of the injury.


Eligibility criteria:
inclusion criteria: * vertebral fracture * injuries to the vertebral spine exclusion criteria: * head trauma * polytrauma

Keywords: vertebral fracture spinal cord injury
a study to evaluate the onset of relief from methacholine-induced bronchoconstriction with chf1535 nexthaler in asthmatic patients.

Conditions: Asthma

Summary: the clinical trial is designed to evaluate the non-inferiority of chf1535 100/6 µg nexthaler versus chf1535 100/6 µg pmdi on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function (i.e. change in forced expiratory volume in the 1st second, fev1, from baseline to 5 min after study drug intake) in asthmatic patients.


Eligibility criteria:
inclusion criteria: * informed consent form obtained * minimum required peak inspiratory flow (pif) to activate nexthaler * pre-bronchodilator fev1 of at least 65% * positive response to methacholine challenge test * previous treatment with low-medium doses of inhaled corticosteroids (ics) or ics/long-acting beta2-agonist (laba) as per global initiative for asthma (gina) 2016 guidelines * for females: non-pregnant, non-lactacting and using highly effective contraceptive methods. exclusion criteria: * clinically relevant and uncontrolled concomitant diseases * abnormal clinically relevant ecg * presence of aortic aneurism * uncontrolled hypertension * intake of non-permitted concomitant medications * participation in another clinical trials in the previous 8 weeks * seasonal variation in asthma * recent occurrence of asthma exacerbations * hypersensitivity to any product used in the trial, including excipients * heavy caffeine drinkers * history of alcohol/drug abuse * smokers
endothelial function in patients with pulmonary arterial hypertension

Conditions: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Pathophysiology; Genetics

Summary: the objectives of the current study are to identify and evaluate new prognostic non-invasive and serological markers in patients with pulmonary hypertension. the focus will be on l-arginine metabolism and to clarify its influence on endothelial function.

the objectives of the current study are to identify and evaluate new prognostic non-invasive and serological markers in patients with pulmonary hypertension. the focus will be on l-arginine metabolism and to clarify its influence on endothelial function. the investigators also want to evaluate differences in plasma concentrations of l-arginine/no metabolites and non-invasively assessed endothelial function based on specific ph-therapy. furthermore, the investigators aim to transfer the results gained from the investigators study population to in-vitro systems in order to carefully characterize the involved signal transduction pathways. thereby the investigators hope to identify potentially new therapeutic targets in ph or patient subgroups preferably benefitting from established therapeutic options.

Eligibility criteria:
inclusion criteria: * proven ph (by right heart catheterization, pap \>25 mmhg, within last 12 months) * age \>18 years * dana point classification i or iv (all subgroups) * declaration of consent exclusion criteria: * pulmonary hypertension not proven by right heart catheterization * eisenmenger's syndrome/reaction * ph other than dana point i and iv * alcohol or drug abuse * non-compliance due to any cause (e.g. severe psychiatric disorder)

Keywords: pulmonary arterial hypertension prognostic factors signal transduction genetics